Measles, Mumps, Rubella And Varicella Virus Vaccine Live (Proquad)

Trade Name : ProQuad

Merck Sharp & Dohme Corp.

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, VACCINE

Strength 10002000010009772 [TCID_50]/.5mL[TCID_50]/.5mL[TCID_50]/.5mL[PFU]/.5mL

MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [CS],Vaccines, Attenuated [CS],Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [CS],Chickenpox Vaccine [CS],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [CS],Actively Acquired Immunity [PE],Vaccines, Attenuated [CS],Live Attenuated Measles Virus Vaccine [EPC],Measles Vaccine [CS],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [CS],Mumps Vaccine [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Measles, Mumps, Rubella And Varicella Virus Vaccine Live (Proquad) which is also known as ProQuad and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 1000; 20000; 1000; 9772 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL per ml. Read more

Measles, Mumps, Rubella And Varicella Virus Vaccine Live (Proquad) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

ProQuadu00ae is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.
ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. ()

A 0.5-mL dose for subcutaneous injection only. ()

The first dose is usually administered at 12 to 15 months of age. ()
A second dose, if needed, is usually administered at 4 to 6 years of age. ()

ProQuad is a suspension for injection supplied as a 0.5-mL single dose vial of lyophilized vaccine to be reconstituted using the sterile diluent supplied .
Suspension for injection (0.5-mL dose) supplied as a lyophilized vaccine to be reconstituted using only accompanying sterile diluent. (, )

No data

History of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine. ()
Primary or acquired immunodeficiency states. ()
Family history of congenital or hereditary immunodeficiency. ()
Immunosuppressive therapy. (, )
Active untreated tuberculosis or febrile illness (>101.3u00b0F or >38.5u00b0C). ()
Pregnancy. (, , )

No data

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with M-M-Ru00ae II and VARIVAXu00ae administered separately. (, , )
Use caution when administering ProQuad to children with a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided. ()
Use caution when administering ProQuad to children with anaphylaxis or immediate hypersensitivity to eggs () or contact hypersensitivity to neomycin. ()
Use caution when administering ProQuad to children with thrombocytopenia. ()
Avoid close contact with high-risk individuals susceptible to varicella since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts. ()
Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG). (, )
Avoid using salicylates for 6 weeks after vaccination with ProQuad. (, , )
Avoid pregnancy for 3 months following vaccination with measles, mumps, rubella, and/or varicella vaccines. (, )

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

The most frequent vaccine-related adverse events reported in u22655% of subjects vaccinated with ProQuad were:n
Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were:n

No data

Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad. ()
ProQuad may be administered concomitantly with type b conjugate vaccine and/or hepatitis B vaccine at separate injection sites. ()
ProQuad may be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites. ()

Pregnancy: Do not administer ProQuad to females who are pregnant. Pregnancy should be avoided for 3 months following vaccination with ProQuad. (, , )

ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of (1) the components of M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynnu2122 (B level) strain of mumps virus propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. The cells, virus pools, bovine serum, and recombinant human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents.
ProQuad, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.5-mL dose contains not less than 3.00 log TCID of measles virus; 4.30 log TCIDof mumps virus; 3.00 log TCID of rubella virus; and a minimum of 3.99 log PFU of Oka/Merck varicella virus.
Each 0.5-mL dose of the vaccine contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of recombinant human albumin, 0.17 mg of sodium bicarbonate, 72 mcg of potassium phosphate monobasic, 60 mcg of potassium chloride; 36 mcg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; <16 mcg of neomycin, bovine calf serum (0.5 mcg), and other buffer and media ingredients. The product contains no preservative.

No data

ProQuad has not been evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility.

Formal studies to evaluate the clinical efficacy of ProQuad have not been performed.
Efficacy of the measles, mumps, rubella, and varicella components of ProQuad was previously established in a series of clinical studies with the monovalent vaccines. A high degree of protection from infection was demonstrated in these studies {14-21}.

No data

No. 4171 u2014 ProQuad is supplied as follows:
(1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4171-00 (package A)
(2) a separate package of 10 vials of sterile water diluent (package B).
Storage
To maintain potency, ProQuad must be stored frozen between -58u00b0F and +5u00b0F (-50u00b0C to -15u00b0C). Use of dry ice may subject ProQuad to temperatures colder than -58u00b0F (-50u00b0C).
Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between
58
F and
5
F (
50
C and
15
C) for up to 18 months. Any freezer (., chest, frost-free) that reliably maintains an average temperature between
58
F and
5
F (
50
C and
15
C) and has a separate sealed freezer door is acceptable for storing ProQuad. Routine defrost cycling of a frost-free freezer is acceptable.
ProQuad may be stored at refrigerator temperature (36u00b0 to 46u00b0F, 2u00b0 to 8u00b0C) for up to 72 hours prior to reconstitution. Discard any ProQuad vaccine stored at 36u00b0 to 46u00b0F which is not used within 72 hours of removal from 5u00b0F (-15u00b0C) storage.
Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.
IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES.
DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
DO NOT FREEZE RECONSTITUTED VACCINE.
Diluent should be stored separately at room temperature (68u00b0 to 77u00b0F, 20u00b0 to 25u00b0C), or in a refrigerator (36u00b0 to 46u00b0F, 2u00b0 to 8u00b0C).
For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90.

Instructions
Provide the required vaccine information to the patient, parent, or guardian.
Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
Inform the patient, parent, or guardian that the vaccine recipient should avoid use of salicylates for 6 weeks after vaccination with ProQuad . tttttttt
Instruct postpubertal females to avoid pregnancy for 3 months following vaccination n
Inform patients, parents, or guardians that vaccination with ProQuad may not offer 100% protection from measles, mumps, rubella, and varicella infection.
Instruct patients, parents, or guardians to report any adverse reactions to their health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at http://www.vaers.hhs.gov.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2005-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-v221-i-fro-rha-1909r009

NDC 0006-4171-0010 Single-dose 0.5-mL Vials
A
Measles, Mumps, Rubella and VaricellaVirus Vaccine LiveProQuad
STORE FROZEN
Measles vaccine: More attenuated Enders' Edmonston strain. Chick cell tissue culture origin.Mumps vaccine: Jeryl Lynnu2122 strain. Chick cell tissue culture origin.Rubella vaccine: Wistar RA 27/3 strain. Human diploid cell (WI-38) culture origin.Varicella vaccine: Oka/Merck strain. Human diploid cell (MRC-5) culture origin.
Contains no preservative. Contains trace quantities of neomycin.
Rx only

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Measles, Mumps, Rubella And Varicella Virus Vaccine Live (Proquad)

Trade Name : ProQuad

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Measles, Mumps, Rubella And Varicella Virus Vaccine Live (Proquad)

Trade Name : ProQuad

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

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NZ Drugs

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